Alembic Pharma gets USFDA nod for Cipro & Dexa Otic Suspension

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. This generic drug is therapeutically equivalent to Sandoz Inc.'s Ciprodex Otic Suspension. The suspension is indicated for treating specific ear infections in pediatric, adult, and elderly patients. The estimated market size for this product was US$110 million for the twelve months ending June 2026. This approval adds to Alembic's portfolio, bringing their total USFDA ANDA approvals to 246.